Jonathan Almeida
Summary
A highly dedicated professional offering an extensive background in the pharmaceutical industry in clinical trials (CT) and data management (DM), regulatory safety, and pharmacovigilance (PV) training. A demonstrated ability to initiate, coordinate and complete projects in a timely and cost-effective manner. Organized and dependable, adept at implementing multi-faceted operational procedures while working alone or as an integral part of a team. Solid people skills - exhibits balance of tact and tenacity when collaborating with individuals on all levels. Strong communication skills - able to visualize and communicate "big picture" goals and provide the means to attain them. A sound, professional attitude, strong work ethic and pride in personal performance.
Overview
9
9
years of professional experience
Work History
MANAGER, DRUG SAFETY OFFICER
PFIZER INC
01.2022 - Current
- Played a key role in the implementation of PVAI (Pharmacovigilance Artificial Intelligence)
- Helped pilot the Pfizer Refugee Leadership Initiative
- Assisted with reviewing, internal SOPs, and working practices (WPs)
- Liaised with vendors to review AE report submissions and contact email address for vendor lists
- Performed daily case review and triage of AE items in the safety mailbox
- Organized, managed, and actively carried out, local pharmacovigilance activities regulatory requirements and Pfizer policies with regards to adverse event monitoring, case management activities, local safety monitoring activities, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity
- Managed daily assignment of case items and queries for colleagues in the US, and coordinated assignments for colleagues in China, while maintaining productivity, by utilizing organizational and time management skills in order to meet strict regulatory compliance goals
- Worked independently to accomplish team goals with minimal supervision
- Ensured regulatory compliance timelines were met for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents
- Acted as a Subject Matter Expert (SME) for suppliers and stakeholders, locally, concerning safety-related issues; and, liaises with key partners (e.g., Business Units, License Partners, Global Drug Safety sites) regarding safety data collection and handling
- Streamlined the drug safety reporting process to improve efficiency and accuracy.
- Collaborated with cross-functional teams to ensure timely submission of safety reports.
- Made decisions independently in both routine case processing and unique situations resolving issues appropriately to achieve desired results.
SENIOR DRUG SAFETY DATA MANAGEMENT SPECIALIST
PFIZER INC
01.2020 - 01.2022
- Managed the AE reporting safety mailbox monitoring AE and SAE reports, medical and vendor queries
- Performed daily case review and triage of AE items in the safety mailbox
- Liaised with Customer Engagement Program (CEP) Managers to ensure accurate submission of AE reports
- Tracked and reviewed the daily mailbox audit reports
- Reviewed, tracked and provided compliance reminder emails and corrective action plans (CAPAs) for delayed AE reports submitted to safety outside of compliance timelines
- Consistently applied regulatory requirements and Pfizer policies
- Reviewed initial unprocessed source documents received from vendors (in addition to processed cases) to verify accuracy, consistency, and compliance with case processing requirements
- Liaised with vendors to review AE report submissions
- Provided oversight and team mentoring on case handling aspects, data extraction, and processing of case information.
DRUG SAFETY DATA MANAGEMENT SPECIALIST
PFIZER INC
01.2018 - 01.2020
- Completed case processing activities
- Reviewed, ranked, processed and documented case-related information: event terms, validity, seriousness, special scenarios, timelines, accuracy and consistency
- Processed cases based on these assessments
- Liaised with key partners, locally, and other stakeholders regrading safety data collection and data reconciliation
- Assessed case criteria to determine appropriate workflow for case processing
- Developed and maintained expertise and knowledge for applicable corporate and global regulations, for guidelines, and Standard Operating Procedures
- Determined reportability of scheduled reports, ensuring adherence to regulatory requirements
- Reviewed, prepared, and completed reports of adverse drug experiences, to determine safety profile of Pfizer's products and to meet regulatory requirements
- Determined local submission of individual and, where appropriate, aggregate safety reports.
US DRUG SAFETY ASSISTANT
PFIZER INC
01.2016 - 01.2018
- Completed local activities relevant to the management of safety data
- Maintained local source documentation as required by legislation (including Archiving / tracking / retrieval)
- Electronic archival of Queries, e-mails, and intake of AEs source documents
- Supported distribution and tracking of distribution of Follow-up letters
- Reviewed quality assurance of follow-up request packages
- Support inspection preparedness activities and quality review initiatives as needed
- Consistently apply Case Receipt policies and practices as per Company SOP
Skills
- PVAI
- ARISg
- MS Word
- Excel
- Power Point
- ARGUS
- MedDRA
- Oracle Clinical
- Strong attention to detail
- Clinical trial monitoring
- Drug safety regulations
Education
Monmouth University, West Long Branch, NJ — Bachelor of Arts in Psychology 2015
Languages
English
Portuguese
Timeline
MANAGER, DRUG SAFETY OFFICER
PFIZER INC
01.2022 - Current
SENIOR DRUG SAFETY DATA MANAGEMENT SPECIALIST
PFIZER INC
01.2020 - 01.2022
DRUG SAFETY DATA MANAGEMENT SPECIALIST
PFIZER INC
01.2018 - 01.2020
US DRUG SAFETY ASSISTANT
PFIZER INC
01.2016 - 01.2018